{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "product_ndc": "13533-636",
      "generic_name": "HEPATITIS B IMMUNE GLOBULIN (HUMAN)",
      "labeler_name": "GRIFOLS USA, LLC",
      "brand_name": "HYPERHEP B",
      "active_ingredients": [
        {
          "name": "HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN",
          "strength": "220 [iU]/mL"
        }
      ],
      "finished": true,
      "packaging": [
        {
          "package_ndc": "13533-636-01",
          "description": "1 VIAL, GLASS in 1 CARTON (13533-636-01)  / 1 mL in 1 VIAL, GLASS (13533-636-10)",
          "marketing_start_date": "19961009",
          "sample": false
        },
        {
          "package_ndc": "13533-636-02",
          "description": "1 SYRINGE, GLASS in 1 CARTON (13533-636-02)  / 1 mL in 1 SYRINGE, GLASS (13533-636-20)",
          "marketing_start_date": "19961009",
          "sample": false
        },
        {
          "package_ndc": "13533-636-03",
          "description": "1 SYRINGE, GLASS in 1 CARTON (13533-636-03)  / .5 mL in 1 SYRINGE, GLASS (13533-636-30)",
          "marketing_start_date": "19961009",
          "sample": false
        },
        {
          "package_ndc": "13533-636-05",
          "description": "1 VIAL, GLASS in 1 CARTON (13533-636-05)  / 5 mL in 1 VIAL, GLASS (13533-636-50)",
          "marketing_start_date": "19961009",
          "sample": false
        }
      ],
      "listing_expiration_date": "20261231",
      "openfda": {},
      "marketing_category": "BLA",
      "dosage_form": "INJECTION",
      "spl_id": "07a45b19-8ed3-48e2-9c0f-9620437fd452",
      "product_type": "PLASMA DERIVATIVE",
      "route": [
        "INTRAMUSCULAR"
      ],
      "marketing_start_date": "19961009",
      "product_id": "13533-636_07a45b19-8ed3-48e2-9c0f-9620437fd452",
      "application_number": "BLA101146",
      "brand_name_base": "HYPERHEP B",
      "pharm_class": [
        "Human Immunoglobulin [EPC]",
        "Immunoglobulins [CS]",
        "Passively Acquired Immunity [PE]",
        "Virus Neutralization [MoA]",
        "Virus-specific Hyperimmune Globulins [EXT]"
      ]
    }
  ]
}